Senior Safety Scientist Lead – Global Pharmacovigilance

Alexion-Pharmaceuticals-; Boston (MA); On-site; USD 133,000 - 199,000; Full time

Benefits offered by this job

401(k) plan

Paid vacation

Paid holidays

Health benefits

Job summary

At Alexion Pharmaceuticals, the Senior Manager, Safety Scientist leads pivotal safety activities across programs, evaluating risks and guiding cross-functional teams with the GPS Medical Director(s). The role emphasizes adherence to global regulations, GxP standards, and AZ procedures within an office-based setting.

The position requires a biology/medicine background with PV experience, strong writing skills, and the ability to communicate complex safety data to diverse stakeholders.

Qualifications

• Bachelor’s degree in a biologic/medical/clinical/nursing field with at least 3 years of experience in drug safety/pharmacovigilance.
• Knowledge of global pharmacovigilance regulations.
• Strong analytical and problem-solving skills.
• Excellent communication and interpersonal skills.
• Strong scientific writing skills.
• Demonstrated learning agility and ability to work independently.
• Good judgement.
• Ability to interact effectively with people of multiple subject areas and cultures globally.

Responsibilities

• Contributing to safety data reviews and analyses for products in designated therapeutic areas.
• Authoring or reviewing safety sections of clinical documents including but not limited to the clinical study protocol, informed consent form, Investigator’s Brochure, statistical analysis plan, clinical study report, and data monitoring committee documents.
• Coordinating, preparing, and completing high-quality aggregate safety reports (e.g., PSUR, PBRER, PADER) for submission to regulatory agencies globally.
• Ensuring the oversight of safety for assigned assets, including implementation and execution of the Safety Strategy and Management Team (SSaMT) and Safety Surveillance Team (SST).
• Leading program and study level safety surveillance including the analysis and communication of safety data, authoring of internal safety review documents, presentation at cross-functional decision-making bodies and documentation/tracking of all signal analysis results.
• Authoring and project management of health authority queries.
• Maintaining accountability for the authoring, review and finalization of risk management plans and contributing to REMS documents.
• Assisting GPS Medical Directors in the development of risk management strategy.
• Training and/or leading junior safety scientists and fellows.
• Supporting activities related to new drug applications and other regulatory filings including authoring, reviewing and providing input to eCTD modules (2.5 and 2.7.4), core product information, and local labels.
• Assisting Global Safety Physicians in developing a strategy for safety-related regulatory activities.
• Proactively leading safety documents by driving timely execution, engaging cross-functional stakeholders, and ensuring adherence to safety governance and regulatory timelines.
• Representing global patient safety as a subject matter authority in clinical study teams and cross-functional meetings.
• Contributing to initiatives for process improvement and cross-departmental process consistency.
• Maintaining a strong, up-to-date solid understanding of evolving global regulations.

Skills

Safety data analysis

Pharmacovigilance regulations

Analytical thinking

Communication skills

Scientific writing

Independent work

Cross-functional collaboration

Risk management

Education

Bachelor's degree in biology/medicine/clinical/nursing

Tools

Power BI

Clinical databases

eCTD knowledge

Job description

At Alexion Pharmaceuticals, the Senior Manager, Safety Scientist leads pivotal safety activities across programs, evaluating risks and guiding cross-functional teams with the GPS Medical Director(s). The role emphasizes adherence to global regulations, GxP standards, and AZ procedures within an office-based setting.

The position requires a biology/medicine background with PV experience, strong writing skills, and the ability to communicate complex safety data to diverse stakeholders.